As “SEND” Submissions Documentation Specialist, you will be working with a driven service team of Documentation and Dossier Specialists. After a training period, this position will be working in a 2-shift schedule to provide real-time support to our clients both in Belgium and in the US.
SEND specifies a way to collect and present nonclinical data in a consistent format. It is one of the required standards for data submission to the US Food and Drug Administration (FDA). In this role, you will be responsible for:
* Generating SEND datasets using the document management systems.
* Writing the corresponding Nonclinical Study Data Reviewer’s Guides in Word and Acrobat PDF.
* Doing an in-depth quality check on the SEND document packages.
* Keeping track of the Global SEND Planning list in Excel and other related activities.
Qualifications
* A bachelor’s degree in office management/business management or equivalent by experience.
* Experience in “SEND” Submissions is an asset.
* Outstanding written and communication skills in English.
* Ability to learn and work with different tools and document management systems.
* Proficient with Microsoft Office, especially Word and Excel.
* Showing initiative, assertiveness in follow-up of requests and pro-active approach.
* Accurate, detail-oriented, and most of all; team player mentality.
Additional Information
* A full-time (40 hours/week) Monday – Friday job.
* A permanent contract with flexible working hours.
* 80% working from home, 20% working from the office.
* Easily reachable by public transportation from central station Antwerp (415/416/417).
* For Day shift, you can start between 7 am - 9:30 am.
* For the Afternoon shift, you start from 14:00 and work till 22:00. This includes a paid lunch break and a shift allowance.
* Work in a fast-growing international organization.
* Eco-Cheques +/- 250 Euro/year.
* Additional 12 ADV days.
* A company well-being program targeting both mental and physical well-being.
* A fantastic team with monthly team lunches, fun teambuilding activities (laser tag, escape rooms, sports, etc.) and above all; a great collaborative international work environment.
* Personal development through learning on the job and additional trainings.
What Happens Next
Our people are the backbone of what we do, so it's incredibly important we find the right individuals to join us. As a potential new recruit, you'll be invited to meet the team in the form of an assessment center or a staged interview process dependent on the role and its requirements, this will give you the opportunity to see what working for Eurofins is really like and enable us to get to know your key skills and strengths.
Your Data
As part of any recruitment process, the company collects and processes personal data relating to job applicants. The company is committed to being transparent about how it collects and uses that data and to meeting its data protection obligations.
Closing Date
We reserve the right to close or extend this position depending on application numbers. Therefore, we would urge candidates to submit an application as early as possible. Due to the high volume of applications we receive, please be aware that if you do not receive a response within 4 weeks of the vacancy expiry date, unfortunately, on this occasion, your application has been unsuccessful.
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